Batch Record Review and Product Release 2018

Overview:

Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.

A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.

Why should you Attend: Recognize regulatory requirements for batch records and batch record review. Discover the essentials of batch record reviewer qualifications and training. Establish a working relationship between production and quality reviewers What to do when a batch fails to meet specifications (discrepancies and deviations).

Areas Covered in the Session:

• Regulatory requirements for Batch Record Review
• What to look for while reviewing batch records, i.e Good Documentation Practices, Compliance to Critical Quality Attributes and Critical Processing Parameters
• Skills and Responsibilities of an Effective Batch Record Reviewer
• Tools for Effective Batch Record Review
• Ensuring Production and Quality Reviewers Coincide with their Reviews
• Extensive Training plan for Batch Record Reviewers and when they can be Considered "Qualified" to Review a Record

Who Will Benefit:

• Quality Assurance Batch Record Reviewers
• Production Personnel
• Production Managers who Review Batch Records

Speaker Profile
Danielle DeLucy MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 17 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations.